At Annual and Special Meeting of Shareholders - Neurochem to officially adopt new name - BELLUS Health - And to provide update on programs including first new natural health product, VIVIMIND(TM)
Tuesday April 15, 7:00 am ET
Neurochem Annual and Special Meeting web cast live
LAVAL, QC, April 15 /PRNewswire-FirstCall/ - At the Annual and Special meeting of Neurochem Inc. (NASDAQ: NRMX - News; TSX: NRM - News), shareholders will be asked to officially adopt the Company's new name, BELLUS Health Inc., which it expects to start using on April 21, 2008, together with the new stock ticker symbols (NASDAQ: BLUS - News; TSX: BLU - News). Neurochem will also present the launch activities that are in preparation for VIVIMIND(TM), the first branded natural health product to be marketed by its new, wholly owned, nutraceutical subsidiary, OVOS Natural Health Inc., to protect memory function. Shareholders will also learn that Neurochem has regained full ownership rights and control on eprodisate (KIACTA(TM)) from Centocor Inc., a wholly owned subsidiairy of Johnson and Johnson, for the prevention and treatment of Amyloid A (AA) amyloidosis.
"Fiscal 2007 was a difficult year for Neurochem, but we have risen to the challenge by adopting an expanded corporate strategy to assure revenue generation in the short-term through the sale of natural health products and long-term development of a rich product pipeline in pharmaceuticals," said Dr. Francesco Bellini, Neurochem's Chairman, President and Chief Executive Officer. "Our name-change to BELLUS Health will reflect the broader scope of our activities, while the creation of our subsidiary, OVOS Natural Health, as well as the imminent launch of VIVIMIND(TM) for memory protection, testify to our determination to move ahead quickly. Our proactive strategy is based on the wealth of our past experience and the unique opportunity that the natural health product market represents to meet the needs of those who could benefit from this product, while helping to fund our longer-term drug development programs geared to future growth," he stated.
"I am particularly pleased to have regained full ownership of KIACTA(TM) given the promising results from our Phase II/III trial and our intention to initiate another Phase III trial and complete the development of this product candidate," Dr. Bellini concluded.
OVOS Natural Health - Launch activities in preparation for VIVIMIND(TM)
Fifteen years of combined scientific research including clinical trials with over 2,000 individuals in Canada, the United States and Europe and millions of dollars invested lie behind OVOS Natural Health's claim that VIVIMIND(TM) can help protect memory function and reduce age-associated brain volume loss normally leading to cognitive problems. The Company is looking to the natural health product market to make homotaurine, a naturally occurring ingredient otherwise found in algae available to the public given its good safety and tolerability profiles and the wealth of data supporting the impact on memory function and brain structures associated with memory and learning.
Following post-hoc analyses, the results in previous human testing clearly showed that homotaurine had a statistically significant dose-dependent effect and reduced by at least 68% (p-value 0.035) the loss of hippocampal volume over time in the individuals tested when compared to the untreated group. An almost statistically significant clinical benefit equivalent to 33% less decline (p-value: 0.065) on their cognitive tests as measured by ADAS-cog was also observed in individuals receiving homotaurine. The launch activities for VIVIMIND(TM) are in preparation.
"No other product on the natural health product market addressing memory function comes with the scientific background for safety and indications of effectiveness that VIVIMIND(TM) can claim," stated Mr. Gary Schmid, newly appointed President and Chief Executive Officer of OVOS Natural Health Inc. "VIVIMIND(TM) is in a class by itself and we plan to make it the leader in the fast growing baby boomer, or zoomer, market where a key concern is to maintain health and delay the effects of aging," he added.
VIVIMIND(TM) will be made available to consumers through traditional retail channels, such as drug stores, mass merchandisers and grocery chains, as well as through leading health food stores. OVOS Natural Health is working towards the launch of a major advertising and information campaign for consumers.
New Pharmaceutical Development Pipeline
As previously announced, Neurochem will initiate a second Phase III clinical trial for eprodisate (KIACTA(TM)) in close cooperation with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA). This investigational product candidate is being developed for the treatment of a rare but devastating disease, Amyloid A (AA) amyloidosis, which attacks the kidney function and often leads to death.
The trial is expected to begin in the fourth quarter of 2008. It will be an international, double-blind, randomized, placebo-controlled and parallel design study of approximately 150 patients to be followed for a period of 24 months.
NC-503 is being studied for the treatment of Type II diabetes and certain features of metabolic syndrome. Results from animal studies using a rat model of diabetes and metabolic syndrome have shown that NC-503 protects the kidney and decreases the glycemic levels in obese diabetic, so-called Zucker rats, when compared to the control group. Treatment with NC-503 correlated with the preservation of 40% more cells secreting insulin than in the control group.
This program has now advanced into a Phase II clinical trial in diabetic patients in Canada. The study is a 26-week, double-blind, placebo-controlled, randomized study. Interim results are expected in late 2008 or early 2009. The screening of the first patient for this study was completed last week.
Leveraging the many years of accumulated knowledge and the experience it has gained in developing tramiprosate (ALZHEMED(TM)) for the treatment of Alzheimer's disease (AD), Neurochem will prioritize and accelerate the development of a prodrug of tramiprosate (ALZHEMED(TM)), a new chemical entity (NCE), for the treatment of AD. A prodrug is a pharmaceutical substance which is administered in an inactive form and, once absorbed, is metabolized in vivo into its active form (in this case, tramiprosate). This NCE has potential patent protection until 2027.
Financial Update
Neurochem indicated that it expects to spend less in fiscal 2008 than in 2007, due in large part to the discontinuation of the European Phase III clinical trial for tramiprosate (ALZHEMED(TM)). The Company completed fiscal 2007 with approximately US$59 million cash on hand, enough to finance the current needs of Neurochem's pharmaceutical and branded nutraceutical activities. Management indicated that additional financing could be contemplated if required and that it can count on the continued support of Picchio Pharma, the Company's major shareholder
